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Major supplier of reusable surgical drapes and gowns faulted.

FDA says Repak Surgical Enterprises does not comply with good manufacturing practice regulations for medical devices

A warning letter was issued by the Federal Food and Drug Administration (FDA) to Repak Surgical Enterprises regarding violations at its facility in Mason, OH. Repak is a joint venture between Standard Textile and Marriott Food & Services that provides reusable surgical drapes and gowns to hospitals.

In the November 27, 1991 letter--which was based on a month-long inspection of the Repak facility--FDA noted numerous quality control failures as well as incidents of strike-through and problems with Repak's sterilization processes.

Until these violations are corrected, the FDA will recommend that the federal government not enter into contracts with the Repak organization.

Repak Background

Repak leases drapes and gowns to client hospitals for use during surgical procedures. After the items have been used, Repak employees collect them, launder them and deliver them back to the hospital in customized "packs" for future use.

Repak claims that the fabric used in its drapes and gowns will survive the "rigors and stresses" of 100 hospital laundry and autoclave cycles, a claim many INDA members dispute. Repak has also made claims--also disputed by INDA members--about the cost competitiveness and comfortableness of its products versus single-use drapes and gowns.

According to the warning letter issued by the Cincinnati, OH office of the Food and Drug Administration, FDA officials conducted an inspection of Repak facilities in Mason from Oct. 8-Nov. 4, 1991. Such inspections are routinely conducted under federal law.

In its inspection, the FDA uncovered numerous shortcomings with the Repak facility. For instance, Repak did not have written records demonstrating how, or even if, it investigated a number of "strike-through" incidents reported by its clients.

In addition, the FDA noted a failure within Repak's quality assurance program regarding its "suter value" testing procedure. This refers to a testing method that is designed to measure the barrier properties of fabrics.

According to the FDA, Repak received five separate complaints from four different hospitals concerning surgical devices that had a suter value below specifications.

Not only did the FDA admonish Repak for the failure of its quality assurance program to correct the problem, it also cited the company for not testing the correct number of garments in the weekly suter test procedure for 35 straight weeks. Moreover, even in cases where a device failed Repak's weekly suter test, the procedure for additional testing was not followed.

One of the more significant violations was Repak's failure to document changes to its process specifications. According to the warning letter, Repak has changed its process specifications for its wash formula on seven separate occasions since it began production, yet the FDA could find no documentation that these changes were qualified before implementation. Repairs and calibrations performed on sterilizers also were not documented or reviewed to determine if revalidation of the sterilizers was required.

The FDA also noted a failure by Repak to establish and implement adequate record keeping procedures. For instance, the FDA found that the device history records (Lot Record Sheets) did not reflect the actual amount of product distributed. In addition, when a sterilization run was aborted, the FDA could find no documentation to show why the cycle was aborted. In some instances there were not even any records of the lots of product that were in the aborted run.

Equipment was also not calibrated according to written procedures. Standard operating procedures, such as those for discarding garments and wearing beard covers, were not adhered to in production areas. Repak did not ensure that devices met "finished device specifications" before they were distributed.

The FDA also cited Repak for the following problems with its Device Masters Records (DMR): production process specifications for using one type of water instead of another were not included in the DMR's; the form for suter testing contained in the DMR's was not the same as the forms used in the production area and the DMR's did not contain quality assurance specifications for devices found to contain foreign objects during production.

Finally, the FDA cited Repak for failure to document that maintenance and preventative maintenance activities are being performed.

Next Step

The FDA staff gave Repak 15 days to formally respond to the warning letter. A response was filed by Repak late last year. Unfortunately, that response was not available to the public because the FDA considers this to be "an ongoing matter." INDA has filed a Freedom of Information Act request with the FDA for a copy of the response but to date, has not received one. In fact, depending on the outcome of this warning, the FDA has said that a copy of Repak's response may never be released.

The only thing that is certain at this time, as far as the FDA is concerned, is that the matter is not closed.
COPYRIGHT 1992 Rodman Publications, Inc.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

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Title Annotation:Capital Comments; Repak Surgical Enterprises
Author:Mayberry, Peter
Publication:Nonwovens Industry
Date:Mar 1, 1992
Words:804
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